Devices

CDRH Cites Gains in Strategic Priorities

CDRH has released a statement of what it accomplished in 2016 toward three 2016-17 strategic priorities — establishing a national evaluation system for medical devices, partnering with patients, and promoting a culture of quality and organizational excellence. The document shows supporting actions the Center took for each of the priorities and how it performed on several target activities.

For establishing a national evaluation system for medical devices, it says, reports have been issued by a multi-stakeholder planning board and the Medical Device Registry task force and a draft guidance was issued describing how real-world evidence may be used to support pre- and post-market regulatory decisions. The number of such decisions that used real-world evidence increased by 85% in 2016, compared to a 2015 baseline. The goal had been to increase it by 40%.

CDRH says it chartered and began to recruit members for a new Patient Engagement Advisory Committee and trained more than 80 of its staff on patient-reported outcomes and patient preference information. It reports beating targets relating to facilitating CDRH interaction with patients and use and transparency of patient input as evidence in decision-making.

To help promote a culture of quality and organizational excellence at CDRH, the Center completed development of its document control system, became an American Society for Quality enterprise member, and collected stakeholder input through Case for Quality forums. It says it tripled the number of staff with quality credentials (the goal had been a 10% increase) and developed metrics and best practices to assess quality system performance and analytical tools to assess device quality by hospital value analysis committees.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome